Job Description
About the position
Stryker is hiring a Senior Software Design Quality Engineer to support our Medical's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) and Software as a non-medical device (SaND) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects. This hybrid role requires candidates to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The standard schedule includes on-site work Monday through Wednesday, with remote work on Thursday and Friday. Candidates must be able to commute to their designated facility as needed.
- Responsibilities
- Executing quality assurance activities for new product development within Stryker's global Digital Health Portfolio.
- Supporting software design and validation efforts by ensuring documentation aligns with Quality Management Systems compliance requirements.
- Collaborating with cross-functional teams (e.g., marketing, R D, regulatory) to support product development and quality initiatives.
- Contributing to risk management documentation under guidance, referencing ISO14971 standards to support product safety assessments.
- Independently executing QA activities for digital health products, ensuring compliance with global regulatory standards (FDA, TGA, EUMDR).
- Participating in software lifecycle reviews, promoting continuous improvement and adherence to industry best practices.
- Engaging in the design and development of medical and non-medical software, including SaMD and MDDS, with growing autonomy.
- Applying standard development methodologies such as SAFe to support mobile and cloud-based solution development.
- Requirements
- Bachelor's degree in science or engineering related discipline.
- Minimum of 2 years of experience as an Engineer in software or quality engineering, contributing to product development, testing, or compliance activities.
- Nice-to-haves
- Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
- Experience supporting the development or quality assurance of Software in a Medical Device (SiMD) and/or Software as a Medical Device (SaMD) or Software as a non-medical device (SaND) with exposure to both Waterfall and Agile methodologies and an understanding of regulatory requirements.
- Foundational knowledge or hands-on experience in cybersecurity or secure software development; certification such as Security+ or CISSP is a plus.
- Familiarity with risk analysis and contributing to Failure Modes and Effects Analyses (FMEAs) is desirable.
- Exposure to mobile, cloud, or AI/ML technologies (e.g., AWS, Azure, iOS, Android), especially in healthcare IT, telehealth, or virtual care environments.
- Benefits
- Salary range of $77,200.00 to $160,800.00 plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
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